Triangulation Bulls Eye and Stone Direct Targeting Pcnl

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ClinicalTrials.gov Identifier: NCT04846699

Recruitment Status : Not yet recruiting

First Posted : April 15, 2021

Last Update Posted : April 15, 2021

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Sponsor:

Information provided by (Responsible Party):

mahmoud eldardery, Assiut University

Study Description

Brief Summary:

To assess the impact of percutaneous renal access technique on outcomes of percutaneous nephrolithotomy in management of renal stones by comparing the Triangulation and ''eye of the needle'' (or bull's eye) and the stone targeted techniques in the following:-

Stone free rate (SFR) (primary outcome).
Complicatins of surgery (primary outcome).
Change in haematocrit pre and postoperative (secondary outcome).
Operative time (secondary outcome).
Duration of hospitalization (secondary outcome). .

7-Fluroscpic screening time (FST) (secondary outcome). . 8- Change in haematocrit pre and postoperative (secondary outcome).

Condition or disease	Intervention/treatment
Endourology	Procedure: per-cutaneous stone extraction

Detailed Description:

Percutaneous nephrolithotomy (PNL) is an appropriate first-line alternative for the management of kidney stones that are larger than 2 cm in diameter and that do not respond to extracorporeal shock wave lithotripsy (SWL) [1,2].

Percutaneous renal access is the most important step in PNL, and the adequacy of access directly affects the success and complication rates of this procedure.

Among C-arm fluoroscopy, computed tomography (CT), and ultrasonography (US), C-arm fluoroscopy is the most commonly used imaging technique to access the intrarenal collecting system [3-4].

Various fluoroscopy techniques have been described for achieving a good access. One can use fluoroscopy or ultrasonography or a combination of both for reaching the target calyx. Each of it has its advantages and disadvantages, and no consensus exists showing the superiority of one or the other [5].

Triangulation and ''eye of the needle'' (or bull's eye) techniques are two common methods to obtain proper percutaneous renal access under fluoroscopy guidance [6-7].

Multiplanar fluoroscopic imaging is essential in both techniques to make a proper renal puncture.

Biplanar access is based on mediolateral and cephalad-caudal movements of the needle, with the depth of the puncture adjusted based on different fluoroscopic projections, including oblique, vertical, and 30° positions [6, 8].

Most published studies of PCNL have focused on evaluating the effect of patient- and stone-related factors such as success rate, extent of bleeding, complication rate, fluoroscopic Screening times (FSTs), and operative time on outcomes. [9-10]

The imaging modalities used for guidance by urologists or radiologists during percutaneous renal access and renal access procedures have also recently been analyzed and compared in terms of outcomes and complications.[11-12]

These studies, however, have not considered the effect of percutaneous renal access technique on outcome. Although the triangulation and the bull's-eye techniques have been evaluated and compared using a biologic model in a published study [13], no clinical study comparing these techniques has been performed.

The aim of this study is to evaluate the impact of percutaneous renal access technique on outcomes of percutaneous nephrolithotomy in management of renal stones by comparing the Triangulation and ''eye of the needle'' (or bull's eye) and the stone targeted technique .

Study Design

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Study Type :	Observational
Estimated Enrollment :	150 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Triangulation, Eye of the Needle and Stone Direct Targeting Percutaneous Renal Access Techniques of Nephrolithotomy : Randomized Controlled Trial
Estimated Study Start Date :	April 20, 2021
Estimated Primary Completion Date :	April 20, 2023
Estimated Study Completion Date :	April 20, 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
group 1 bulls eye localization	Procedure: per-cutaneous stone extraction percutaneous nephrolithotripsy for renal stones by different renal access
group 2 stone targeted technique renal access	Procedure: per-cutaneous stone extraction percutaneous nephrolithotripsy for renal stones by different renal access
group 3 triangulation renal access technique	Procedure: per-cutaneous stone extraction percutaneous nephrolithotripsy for renal stones by different renal access

Outcome Measures

Primary Outcome Measures :

stone free rate [ Time Frame: 48 hours postoperative ]
outcome of residual stone postoperative
complication of surgery [ Time Frame: from day one post-operative to 3 months ]
fever , urine leakage , stent of ureter , sepsis, other intervention

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Sampling Method:	Non-Probability Sample

Study Population

all patients presented to endourology clinic by renal stone and complianting and fit for surgery.

Criteria

Inclusion Criteria:

- The study will include all adult patients that with renal stones larger than 2 cm in diameter who will attend our endourology outpatient clinic from Jan 2021 to February 2023 and consented to participate in the study.

Exclusion Criteria:

- 1-Patients with urinary system anomalies as horseshoe kidney, ectopic pelvic kid.

2-Patients with skeletal malformations. 3-Bleeding tendency and ongoing anticoagulant therapy. 4-Pregnancy. 5-Patients who refuse to be involved in the trial documentation.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846699

Contacts

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Contact: mahmoud abdo eldardery	01008763519	m.eldardery91@gmail.com

Locations

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Egypt
NIH
Assiut, Egypt, 20892

Sponsors and Collaborators

Assiut University

More Information

Publications:

Schmahl FW, Betz E, Talke H, Hohorst HJ. [Energy rich phosphates and metabolites of energy metabolism in the cerebral cortex in the cat]. Biochem Z. 1965 Sep 30;342(5):518-31. German.

Ashley FL. Implications of wound healing research. A meeting ground for experimental biology and clinical medicine. Plast Reconstr Surg. 1969 Feb;43(2):190-1.

Meshkov SL, Seltzer SE, Finberg HJ. CT detection of intraabdominal disease in patients with lower extremity signs and symptoms. J Comput Assist Tomogr. 1982 Jun;6(3):497-501.

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Responsible Party:	mahmoud eldardery, dr mahmoud abdo el dardery, Assiut University
ClinicalTrials.gov Identifier:	NCT04846699
Other Study ID Numbers:	new pcnl approch
First Posted:	April 15, 2021 Key Record Dates
Last Update Posted:	April 15, 2021
Last Verified:	April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

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